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ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. Organizations seeking to demonstrate compliance with regulatory requirements – whether for CE marking, FDA quality system expectations, or MDSAP participation – depend on qualified internal auditors to verify that their QMS is effectively implemented and maintained.
This online Auditor training prepares you to contribute meaningfully to your organization's internal audit program. You will learn how to conduct professional internal audits, identify nonconformities, and support corrective action processes. Through a structured curriculum combining theoretical knowledge with practical application, you will develop the competence to audit medical device quality management systems against ISO 13485:2016 requirements.
The course is delivered entirely online and is self-paced, allowing you to progress through the material according to your own schedule. Upon successful completion, you will receive a certificate documenting your training as an ISO 13485 Auditor.
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An effective internal auditor does more than check compliance boxes. They help their organization identify improvement opportunities and strengthen the quality management system. A competent ISO 13485 auditor must be able to:
This course develops these capabilities through structured lessons, practical examples, and audit resources you can apply immediately in your organization.
The training is organized into eight focused sessions that build your knowledge progressively. Sessions include:
Session 1: Overview of ISO 13485:2016
An introduction to the ISO 13485 standard – its purpose, scope, and position within the medical device regulatory landscape. You will understand who uses this standard, why certification matters, and how the standard relates to regulatory requirements.
What you'll learn: The role of ISO 13485 in medical device quality management and its relationship to global regulatory frameworks.
Session 2: ISO 13485:2016 Principles
An examination of the foundational principles that underpin effective quality management in medical device organizations. Topics include customer focus, leadership engagement, process approach, evidence-based decision making, and continual improvement.
What you'll learn: How the eight quality management principles apply specifically to medical device organizations.
Session 3: ISO 13485:2016 Requirements
A comprehensive clause-by-clause review of the ISO 13485:2016 standard. You will examine each requirement in depth, understanding what constitutes acceptable evidence of conformity. Particular attention is given to areas where organizations commonly need guidance.
What you'll learn: Detailed understanding of ISO 13485:2016 requirements and how to evaluate conformity during an internal audit.
Session 4: Control of Documents and Records
A focused examination of documented information requirements. You will learn the practical differences between documents (which are maintained and updated) and records (which are retained as evidence). The session covers document approval, distribution, version control, and retention requirements.
What you'll learn: How to audit document control systems and identify when documentation is insufficient or ineffective.
Session 5: ISO 13485 Internal Audit Process
This session introduces the complete internal audit cycle, from planning through follow-up. You will learn audit methodologies, how to prepare for an audit, and how to conduct audit activities professionally.
What you'll learn: How to plan and conduct internal audits of medical device quality management systems.
Session 6: ISO 13485 Internal Audit Records
Audit proceedings and findings must be documented according to ISO 13485 requirements. This session covers audit preparation documentation, conducting the audit and gathering evidence, audit reporting, and audit completion with follow-up activities.
What you'll learn: How to properly document audit activities and maintain records that demonstrate compliance.
Session 7: Risk Management
ISO 13485 requires risk-based thinking throughout the quality management system. This session explains how risk considerations apply to processes, products, and the QMS itself. You will learn to evaluate whether an organization has appropriately identified and addressed risks.
What you'll learn: How to assess risk management processes during an internal audit and identify gaps in risk-based thinking.
Session 8: Steps for ISO 13485 QMS Installation & Certification
The final session examines the steps necessary to implement an ISO 13485 Quality Management System for Medical Devices and achieve certification. Understanding this process helps auditors provide valuable insights during internal audits.
What you'll learn: The implementation and certification pathway, and how internal audits support this process.
The course provides a comprehensive set of resources that support your learning during the training and serve as valuable references afterward:
This training is designed for individuals who need to develop or formalize their competence in auditing medical device quality management systems. Typical participants include:
The course is appropriate for those new to auditing as well as experienced professionals seeking to update their knowledge of ISO 13485:2016.
Note: If you need to perform external audits, conduct solo audits, lead audit teams, or conduct consulting activities, the ISO 13485:2016 Lead Auditor Training is a better choice.
The training program includes session exams and a comprehensive final examination. The assessments are in multiple-choice format and are designed to verify your understanding of the course material. To pass, you need a score of 60% or higher. If you do not pass on your first attempt, you may retake any exam at no additional charge.
Graduates receive a Certificate of Completion bearing the Exemplar Global accreditation mark. This certificate documents your successful completion of ISO 13485 Auditor training and successful completion of the examinations.
Certificates are issued in digital format upon passing the final examination. You may download, add to LinkedIn, and print your certificate directly from your course dashboard.
Complete course access including dashboard login, downloadable handouts, and certificate.
Self-paced learning – complete the 16 hours of content on your schedule.
Instructor access and technical support whenever you need assistance.
30-Day Money-Back Guarantee – enroll risk-free.
Instant access after enrollment with 3 months to complete.
Learn on any device – Windows, Mac, iOS, or Android.
Isabella Torres
20 July 2025
Absolutely fantastic course! The ISO 13485 Auditor Training gave me the confidence to handle internal audits for our medical device company. The audit checklist with ...
Clara Nguyen
8 April 2025
This course was a game-changer for me as a new internal auditor. The content was clear, with practical examples that made ISO 13485 requirements easy ...
Exemplar Global Certified
We are TPECS certified – a distinction held by only a select group of training organizations worldwide.
Career-Focused Training
Acquire practical skills you can apply immediately – and the certification to prove it.
Learning Resources
Courses include materials you can download, keep, and refer back to long after completion.
Learn on Your Schedule
Self-paced format lets you pause, resume, and switch between devices without losing progress.
Once enrolled, you have 3 months access to the course content (can be extended upon request). During this time you can complete the training at your own pace and return to review materials whenever you need to refresh your knowledge.
Course access ends upon successfully completing the final exam.
Auditor training prepares you to participate in internal audits as a team member.
Lead Auditor training covers additional competencies required to plan audits, lead audit teams, and manage the entire audit program.
Auditor certification is ideal for those beginning their auditing career or contributing to internal audit programs.
Yes. The audit checklists provided with the course are designed to be practical tools that you can customize and use for internal audits within your organization. They provide a structured starting point that you can adapt to your specific processes.
To derive maximum benefit from this training, participants should have a general understanding of quality management system concepts and familiarity with the Plan-Do-Check-Act (PDCA) cycle.
A solid understanding of these concepts is best obtained through our ISO 9001 training.
Prior experience with medical device regulations is helpful but not essential.
While we don't have a sample version of this ISO 13485 course available, you can try the entire course without risk! Your purchase includes our comprehensive 30-Day Money-Back Guarantee.
The charts below show our approval ratings based on post-course surveys from 2000+ learners. Enroll risk-free with our 30-Day Money-Back Guarantee.
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Become a Certified ISO 13485 Lead Auditor. This Exemplar Global-accredited 40-hour online course teaches you to plan, lead and report on audits of medical device quality management systems. Includes practical audit demonstrations, checklists, and the official exam.
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Become a Certified ISO 9001 Auditor. Learn to conduct internal QMS audits as a team member. Exemplar Global TPECS accredited with official 110-question exam. 100% online.
